The Principals of Quality by Design

The application of the Principals of Quality by Design will built QUALITY into a product from an understanding of the product and process and knowledge of the Critical to Quality attributes and Critical Process parameters involved in manufacturing the product to achieve the optimum Quality Target Product Profile.

The lecture will review the systemic, knowledge and risk-based quality methodology used to ensure the consistency of product, and will provide a case study in which to demonstrate the application of the Quality By design principals, and will provide an assessors view of the measures proposed in the lecture “Regulatory Assessment requirements of Quality by Design data”.

Credits: 3 CPD / CME

No. of Hours: 3 hrs

Learning Objectives: 

 This course will provide the key steps used in Quality by Design , and which will include the development of the API manufacturing process, Formulation of the Drug product and standards for batch release, the essential part of the process is to assure the control of quality by qualifying the following controlling factors for the product;

• Quality Target Product Profile (QTPP)
• Critical Quality Attributes (CQA)
• Critical Process Parameters (CPP)
• Design Space (DS)
• Control Strategy
• Process Analytical Technology (PAT)

Who Should Enroll:

All Staff involved in Pharmaceutical, Product Development, Clinical assessment, Manufacturing, Distribution, and Registration.

1. Principals and Techniques of the Quality Risk Management CME / CE

   

   Principals and Techniques of the Quality Risk Management are required to determine if a Product or Process deviation presents a potential risk to the Patient and if so, how it  can be mitigated to ensure the  patients safety.

   This eLearning course provides the principles and tools which can be used to Manage the Risk to Quality of Medicines which can be applied to different aspects of pharmaceutical quality.

   This includes all aspects involved in the Development , manufacture and supply of drug substances to assure the Quality Safety and Efficacy of medicines for Patients

   Credits: 4 CPD / CME

   No. of Hours: 4 hrs

   Learning Objectives: 

   This course will provide an introduction to the skills and competencies required, to Assess and control out of specification and Product/Process deviation by Quality Risk Management. The candidate will learn how to asses and mitigate risk by using techniques such as Risk cause analysis and failure mode Effect analysis to identify and mitigate the potential risk.

   Who Should Enroll:

   Persons  involved in Pharmaceutical Processes – Product Development, Clinical assessment, Manufacturing , Distribution, Pharmacovigilance, and Dispensing medicines to the patient

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2. What you need to know about Pharmaceutical Quality Management Systems CME / CE

   This course will provide the Essential Practice standards to ensure that medicines have been produced in accordance with the international Quality Management Standards to ensure patient safety.

   Significant increases of adulterated and counterfeit Drugs entering the medicines supply chain due mainly to a failure in the Quality management stem, which requires to be corrected by all persons responsible for the distribution of medicines.

   A Quality Management System (QMS) is a collection of processes focused on consistently achieving the quality objectives and are expressed as the organizational structure, policies, procedures, processes and resources needed to provide patients with a Quality Service.

   This course combines the technical requirements of Good Pharmaceutical Practice as stated in ICH Q10 with the business needs of ISO 9001 and applies them to the management of pharmaceutical products supplied to patients

   Credits: 4 CPD / CME

   No. of Hours: 4 hrs

   Learning Objectives: 

   This course has been prepared in accord with the latest WHO Good Pharmaceutical Practice standards for ensuring that all dispensed Medicines meet the required standards of Quality, Safety and Efficacy as defined by the WHO Annex 1 Quality Management covering a number of factors, which ensures the quality of medicines and Patient safety.

   Who Should Enroll:

   ALL Persons involved in the Practice of Pharmacy which should include – Product Development, Clinical assessment, Manufacturing, Distribution, Hospital and Dispensing medicines to the patient

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